Gannex has just announced that they have dosed the first patient in their Phase 2 clinical trial examining ASC42 as a treatment for those diagnosed with primary biliary cholangitis (PBC).
ASC42
ASC42 is a Farnesoid X receptor (FXR) agonist which is selective and non-steroidal.
A Phase 1 trial conducted in the United States demonstrated that pruritus was not observed throughout 14 days of once-daily treatment with ASC42. This trial examined a 15mg dose. This trial also demonstrated that the Fibroblast Growth Factor 19 decreased by 1,780% by the final day of treatment, and the average low density lipoprotein cholesterol was maintained at normal levels.
Researchers are excited about this treatment due to its potential to maintain normal LDL-C levels and an absence of pruritus.
Phase 2 Trial
This Phase 2 Trial is being conducted in China. The investigation is examining three treatment dosages (5mg, 10mg, and 15mg). These doses are being compared to a placebo treatment.
Researchers hope to enroll 100 PBC patients who have not had an adequate response to current treatments or have been deemed unable to tolerate Ursodeoxycholic acid (UDCA). UDCA is currently the only approved treatment for PBC in China, but 40% of all patients either have an inadequate response or find the therapy intolerable.
In the United States, obeticholic acid (OCA) is approved as a treatment for those who do not have an adequate response to UDCA. However, this treatment is also not the perfect solution. Those who take OCA have higher pruritus rates as well as LDL-C levels.
In the Phase 2 trial, treatment will be given for 12 weeks.
Researchers hope to conclude this investigation by the end of this year.
Phase 3 Trial
A Phase 3 trial has already been approved for this indication by the China National Medical Products Administration. This trial will include 210 patients and will be initiated as soon as the Phase 2 trial has ended, and registration with the Administration is confirmed.
You can read more about this treatment and its novel potential here.
